A Study of Anginera In Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery

Status unconfirmed · Phase 1

Conditions studied: Coronary Artery Disease

In brief

This is a first in man, Phase I safety study of Anginera in adults with Left Ventricular Dysfunction (LVD) and Reversible Myocardial Ischemia undergoing a CABG procedure.

Key facts

Study ID

NCT00364390

Run by

Theregen, Inc.

People needed

12

Starts

2006-04-01

Expected to finish

2009-02-01

Last updated by the study team

2009-03-30

Who can join

Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients have been referred for CABG
• Left ventricular ejection fraction (LVEF) greater than 20%
• Patients have CAD involving at least two (2) coronary arteries, with at least one or more vessel(s) having disease not amenable to bypass grafting or PCI
• There is a region of myocardium served by the vessel(s) defined above that has objective evidence of multi-distribution reversible ischemia based on a 17-segment assessment of reversible defects on SPECT/Thallium.

You may not qualify if…

• Subjects meeting any of the following criteria will be excluded from the study:
• Patient undergoing valve replacement or valve modification
• Patient with significant or malignant ventricular arrhythmias, defined as a patient being treated for ventricular tachycardia and/or ventricular fibrillation with an implantable cardioverter/defibrillator (ICD) or a patient being treated with Amiodarone for these same tachyarrhythmias. (Note: having an implantable cardioverter/defibrillator (ICD) per se, in a patient who does not have significant or malignant ventricular arrhythmias, does not exclude the patient from this study.)
• Patient requires urgent coronary artery bypass surgery

Where it is running

• Yale University School of Medicine, — New Haven, Connecticut, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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